# K013916: Melker Emergency Cricothyrotomy Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook, Inc.
- Decided: Dec 20, 2001 after 23 days
- Product code: BWC (Needle, Emergency Airway)
- Device class: 2
- Regulation: 21 CFR 868.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010016 (2001). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010016: Melker Cuffed Emergency Cricothyrotomy Catheter, Cook, Inc. (2001) Summary page 2.

## Most influential descendants
- K130405: Rusch Easycric Emergency Cricothyrotomy Set (2013), 0 descendants of its own
- K050166: Portex Emergency Cricothyroidotomy Kit (2005), 0 descendants of its own

## Indications for use
Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.

Source page: https://510kreport.com/device/K013916
Methodology: https://510kreport.com/methodology